PROPPER Prospective Registry of Outcomes With Penile Prosthesis

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01383018
• Collaborator: (none)
• Enrollment: 1,457
• Locations: 11
• Actual Duration (Months): 85.4
• Patients Per Site: 132.5
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The purpose of this observational registry is to collect and better understand "real-world" outcomes for men undergoing penile implant surgery to treat erectile dysfunction.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction; Impotence	Device: AMS Penile Prosthesis Devices

Detailed Description

A prospective, multi-center, observational registry to be conducted at multiple sites throughout the United States and Canada, to collect "real-world" penile prosthetic outcomes according to investigators' standard of care. Using questionnaires as well as electronic data collection, investigating physicians will prospectively measure patient responses at regular intervals over a one- to five year period. The physician researchers have identified key metrics for the study including effectiveness, durability, complications, and patient satisfaction; quality of life will also be analyzed, being defined through several validated patient surveys.

Study Design

• Study Type: Observational
• Actual Enrollment: 1457 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Registry of Outcomes With Penile Prosthesis for Erectile Restoration (PROPPER)
• Actual Study Start Date: Jun 13, 2011
• Actual Primary Completion Date: Nov 30, 2017
• Actual Study Completion Date: Jul 25, 2018

Arms and Interventions

Arm	Intervention/Treatment
AMS penile prosthesis receipients Men for whom an AMS penile prosthesis is recommended	Device: AMS Penile Prosthesis Devices; Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.; Other Names: AMS 700 AMS Ambicor AMS Spectra

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Penile Prosthesis Overall Subject Satisfaction [1 year, post-implantation]

   Penile prosthesis overall subject satisfaction (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

2. Number of Participants With Penile Prosthesis That Are Using the Device [1 year, post implantation]

   Number of subjects using penile prosthesis at 1 year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

3. Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is. [1 year, post implantation]

   Penile prosthesis use at year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

4. Number of Times Per Month Participants With Penile Prosthesis Are Using the Device. [1 year, post implantation]

   Penile prosthesis use at 1 year measured in number of times per month (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

5. Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use [1 year, post implantation]

   Penile prosthesis reasons for non-use at 1 year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

6. Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired [1 year, post implantation]

   Number of penile prosthesis subjects using the device but indicated that they were not using as often as desired (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

7. Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied [1 year, post implantation]

   Reason why subject is using penile prosthesis less than desired or dissatisfied (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.

Other Outcome Measures

1. Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years [Baseline through 5 years]

   Penile prosthesis International Index of Erectile Function (IIEF-5) score (effectiveness objective 2) measured using a validated, multi-dimensional, self-administered questionnaire. Overall responses are reported. A higher score demonstrates an improvement in erectile function while a lower score indicates a loss of erectile function. The 5-question International Index of Erectile Function (IIEF-5) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0 to 5 is awarded to each of the 5 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The subscales are summed to calculated the total score. The minimum total score for this questionnaire is 0 with a maximum of 30.

2. Erection Hardness Scale Over Five Years [Baseline through 5 years]

   The Erection Hardness Scale (EHS), an easy-to-use, four-point scale for erectile dysfunction, provides a reliable measure of erection hardness and an indicator of other health and wellbeing outcomes, according to new data reported at the European Association of Urology. EHS rates the hardness of erection on a scale of zero to four, with four being the maximal score. A higher score indicates a harder penis while a lower score indicates greater dysfunction.

3. American Urology Association - Symptom Index Over Five Years [Baseline through 5 years]

   The AUA-SI contains seven symptoms questions which include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total score of maximum 35 points from "non-missing" items. The lower score means a better quality of life.

4. UCLA Prostate Cancer Index Over Five Years [Baseline through 5 years]

   The University of California Los Angeles-Prostate Cancer Index -UCLA-PCI is a validated, twenty question questionnaire to asses impact of treatment for early stage prostate cancer on quality of life. The UCLA-PCI is analyzed in six sections, Sexual Function and Sexual Bother, Urinary Function and Urinary Bother, and Bowel Function and Bowel Bother. This is to measure not just the impact on function but also the quality of life impact. The UCLA PCI domain is scored on a scale of 0-100 points with higher values representing better outcomes.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Men diagnosed with erectile dysfunction (ED) for whom an AMS penile prosthesis is recommended by their physician are eligible for inclusion. Potentially eligible men should also meet the following inclusion criteria for study enrollment:

• Willing and able to provide written informed consent prior to enrollment (if applicable).

• Willing to be seen or contacted by phone by the investigator and answer at least 2 questions related to satisfaction and device use 1 year following implantation of an AMS penile prosthesis.

Exclusion Criteria:

• Men who are deemed by their physician to be not suitable for a penile implant will be excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology Centers of Alabama	Homewood	Alabama	United States	35209
2	El Camino Urology Medical Group	Mountain View	California	United States	94040
3	Kaiser Permanente	San Diego	California	United States	92154
4	SIU School of Medicine	Springfield	Illinois	United States	62794-9664
5	Ark-LA-Tek	Bossier City	Louisiana	United States	71111
6	Lahey Clinic	Burlington	Massachusetts	United States	01805
7	The Urology Team	Austin	Texas	United States	78715
8	Baylor College of Medicine	Houston	Texas	United States	77030
9	Urology San Antonio Research, PA	San Antonio	Texas	United States	78229
10	University of Utah	Salt Lake City	Utah	United States	84132
11	University of Ottawa	Ottawa	Ontario	Canada	K1H 8L6

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Gerard Henry, MD, Ark-LA-Tek
• Principal Investigator: Anthony J. Bella, MD, University of Ottawa
• Principal Investigator: Edward Karpman, MD, El Camino Urology Medical Group
• Principal Investigator: LeRoy Jones, MD, Urology San Antonio Research PA
• Principal Investigator: Bryan T Kansas, MD, The Urology Team
• Principal Investigator: Brian Christine, MD, Urology Centers of Alabama
• Principal Investigator: Kevin McVary, MD, SIU School of Medicine
• Principal Investigator: James Hotaling, MD, University of Utah
• Principal Investigator: Mohit Khera, MD, Baylor College of Medicine
• Principal Investigator: Eugene Rhee, MD, Kaiser Permanente

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 17, 2016

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01383018
• Other Study ID Numbers: U0552
• First Posted: Jun 28, 2011
• Last Update Posted: Feb 12, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Boston Scientific Corporation: Erectile Dysfunction (ED); Penile Implant; Impotence; Penile Prosthesis; Registry
• Additional relevant MeSH terms: Erectile Dysfunction

Study Results

Participant Flow

Arm/Group Title	AMS Penile Prosthesis Recipients
Arm/Group Description	Men for whom an AMS penile prosthesis is recommended AMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.
Period Title: Overall Study
STARTED	1457
COMPLETED	1082
NOT COMPLETED	375

Baseline Characteristics

Arm/Group Title	AMS Penile Prosthesis Recipients
Arm/Group Description	Men for whom an AMS penile prosthesis is recommended AMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.
Overall Participants	1380
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.8 (9.7)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	1380 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	77 5.6%
Not Hispanic or Latino	1303 94.4%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 0.2%
Asian	15 1.1%
Native Hawaiian or Other Pacific Islander	3 0.2%
Black or African American	187 13.6%
White	1152 83.5%
More than one race	0 0%
Unknown or Not Reported	20 1.4%
Primary ED etiology (Count of Participants)
Radical prostatectomy (RP)	369 26.7%
Diabetes	283 20.5%
Cardiovascular disease	251 18.2%
Peyronies disease	123 8.9%
Priaprism	19 1.4%
Other	335 24.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Penile Prosthesis Overall Subject Satisfaction
Description	Penile prosthesis overall subject satisfaction (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
Time Frame	1 year, post-implantation

Outcome Measure Data

Analysis Population Description

Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit.

Arm/Group Title	All AMS Penile Prosthesis Recipients - Total Reponses	AMS 700	AMS Ambicor	Spectra
Arm/Group Description	Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra, only Men for whom a Spectra penile prosthesis was recommended
Measure Participants	1082	1050	21	11
Very Dissatisfied	34 2.5%	34 NaN	0 NaN	0 NaN
Dissatisfied	37 2.7%	35 NaN	2 NaN	0 NaN
Neither Satisfied nor Dissatisfied	71 5.1%	68 NaN	2 NaN	1 NaN
Satisfied	297 21.5%	286 NaN	5 NaN	6 NaN
Very Satisfied	643 46.6%	627 NaN	12 NaN	4 NaN

2. Primary Outcome

Title	Number of Participants With Penile Prosthesis That Are Using the Device
Description	Number of subjects using penile prosthesis at 1 year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
Time Frame	1 year, post implantation

Outcome Measure Data

Analysis Population Description

Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit.

Arm/Group Title	All AMS Penile Prosthesis Recipients - Total Reponses	AMS 700	AMS Ambicor	Spectra
Arm/Group Description	Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra, only Men for whom a Spectra penile prosthesis was recommended
Measure Participants	1082	1050	21	11
Count of Participants [Participants]	984 71.3%	956 NaN	18 NaN	10 NaN

3. Primary Outcome

Title	Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is.
Description	Penile prosthesis use at year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
Time Frame	1 year, post implantation

Outcome Measure Data

Analysis Population Description

Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit who answered that they were using the device and responded to how often they were using it.

Arm/Group Title	All AMS Penile Prosthesis Recipients - Total Reponses	AMS 700	AMS Ambicor	Spectra
Arm/Group Description	Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra, only Men for whom a Spectra penile prosthesis was recommended
Measure Participants	895	867	18	10
Less than once per month	58 4.2%	56 NaN	1 NaN	1 NaN
More than once per month	837 60.7%	811 NaN	17 NaN	9 NaN

4. Primary Outcome

Title	Number of Times Per Month Participants With Penile Prosthesis Are Using the Device.
Description	Penile prosthesis use at 1 year measured in number of times per month (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
Time Frame	1 year, post implantation

Outcome Measure Data

Analysis Population Description

Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit who hand answered that they were using the device and responded to how many times per month they were using it.

Arm/Group Title	All AMS Penile Prosthesis Recipients - Total Reponses	AMS 700	AMS Ambicor	Spectra
Arm/Group Description	Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra, only Men for whom a Spectra penile prosthesis was recommended
Measure Participants	490	467	17	6
Mean (Standard Deviation) [Number of times per month]	6.3 (5.5)	6.3 (5.6)	5.4 (3.3)	5.2 (4.3)

5. Primary Outcome

Title	Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use
Description	Penile prosthesis reasons for non-use at 1 year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
Time Frame	1 year, post implantation

Outcome Measure Data

Analysis Population Description

Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit who had answered that they were not using the device and responded to the reason for non-use.

Arm/Group Title	All AMS Penile Prosthesis Recipients - Total Reponses	AMS 700	AMS Ambicor	Spectra
Arm/Group Description	Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra, only Men for whom a Spectra penile prosthesis was recommended
Measure Participants	89	87	2	0
Loss of partner	8 0.6%	7 NaN	1 NaN	0 NaN
Partner disinterest	9 0.7%	8 NaN	1 NaN	0 NaN
Device problem	8 0.6%	8 NaN	0 NaN	0 NaN
Device dissatisfaction	17 1.2%	17 NaN	0 NaN	0 NaN
Health decline	13 0.9%	13 NaN	0 NaN	0 NaN
Other reason	34 2.5%	34 NaN	0 NaN	0 NaN

6. Primary Outcome

Title	Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired
Description	Number of penile prosthesis subjects using the device but indicated that they were not using as often as desired (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
Time Frame	1 year, post implantation

Outcome Measure Data

Analysis Population Description

Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit.

Arm/Group Title	All AMS Penile Prosthesis Recipients - Total Reponses	AMS 700	AMS Ambicor	Spectra
Arm/Group Description	Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra, only Men for whom a Spectra penile prosthesis was recommended
Measure Participants	1082	1050	21	11
Count of Participants [Participants]	109 7.9%	96 NaN	9 NaN	4 NaN

7. Primary Outcome

Title	Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied
Description	Reason why subject is using penile prosthesis less than desired or dissatisfied (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.
Time Frame	1 year, post implantation

Outcome Measure Data

Analysis Population Description

Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit and responded that they were using the device less than desired or dissatisfied.

Arm/Group Title	All AMS Penile Prosthesis Recipients - Total Reponses	AMS 700	AMS Ambicor	Spectra
Arm/Group Description	Men for whom an AMS penile prosthesis is recommended AMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.	AMS 700, only Men for whom an AMS 700 penile prosthesis was recommended	AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended	Spectra, only Men for whom a Spectra penile prosthesis was recommended
Measure Participants	133	117	11	5
Loss of partner	4 0.3%	4 NaN	0 NaN	0 NaN
Partner disinterest	9 0.7%	8 NaN	0 NaN	1 NaN
Device problem	6 0.4%	5 NaN	1 NaN	0 NaN
Device dissatisfaction	14 1%	14 NaN	0 NaN	0 NaN
Health decline	13 0.9%	12 NaN	1 NaN	0 NaN
Other reason	87 6.3%	74 NaN	9 NaN	4 NaN

8. Other Pre-specified Outcome

Title	Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years
Description	Penile prosthesis International Index of Erectile Function (IIEF-5) score (effectiveness objective 2) measured using a validated, multi-dimensional, self-administered questionnaire. Overall responses are reported. A higher score demonstrates an improvement in erectile function while a lower score indicates a loss of erectile function. The 5-question International Index of Erectile Function (IIEF-5) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0 to 5 is awarded to each of the 5 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The subscales are summed to calculated the total score. The minimum total score for this questionnaire is 0 with a maximum of 30.
Time Frame	Baseline through 5 years

Outcome Measure Data

Analysis Population Description

Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional.

Arm/Group Title	All AMS Penile Prosthesis Recipients - Total Reponses
Arm/Group Description	Men for whom an AMS penile prosthesis was recommended AMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving a marketed AMS penile prosthesis.
Measure Participants	1194
Baseline	6.4 (5.2)
1 year	20.6 (6.4)
2 year	20.4 (6.6)
3 year	21.2 (6.1)
4 year	20.6 (6.8)
5 year	21.2 (6.2)

9. Other Pre-specified Outcome

Title	Erection Hardness Scale Over Five Years
Description	The Erection Hardness Scale (EHS), an easy-to-use, four-point scale for erectile dysfunction, provides a reliable measure of erection hardness and an indicator of other health and wellbeing outcomes, according to new data reported at the European Association of Urology. EHS rates the hardness of erection on a scale of zero to four, with four being the maximal score. A higher score indicates a harder penis while a lower score indicates greater dysfunction.
Time Frame	Baseline through 5 years

Outcome Measure Data

Analysis Population Description

Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional.

Arm/Group Title	All AMS Penile Prosthesis Recipients - Total Reponses
Arm/Group Description	Men for whom an AMS penile prosthesis was recommended AMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving a marketed AMS penile prosthesis.
Measure Participants	1209
Baseline	1.0 (1.1)
1 year	3.4 (1.0)
2 year	3.5 (1.0)
3 year	3.5 (0.9)
4 year	3.5 (1.0)
5 year	3.5 (0.9)

10. Other Pre-specified Outcome

Title	American Urology Association - Symptom Index Over Five Years
Description	The AUA-SI contains seven symptoms questions which include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total score of maximum 35 points from "non-missing" items. The lower score means a better quality of life.
Time Frame	Baseline through 5 years

Outcome Measure Data

Analysis Population Description

Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional.

Arm/Group Title	All AMS Penile Prosthesis Recipients - Total Reponses
Arm/Group Description	Men for whom an AMS penile prosthesis was recommended AMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving a marketed AMS penile prosthesis.
Measure Participants	1114
Baseline	9.0 (6.9)
1 year	7.9 (6.6)
2 year	8.8 (7.0)
3 year	8.2 (6.5)
4 year	8.1 (6.3)
5 year	8.1 (5.7)

11. Other Pre-specified Outcome

Title	UCLA Prostate Cancer Index Over Five Years
Description	The University of California Los Angeles-Prostate Cancer Index -UCLA-PCI is a validated, twenty question questionnaire to asses impact of treatment for early stage prostate cancer on quality of life. The UCLA-PCI is analyzed in six sections, Sexual Function and Sexual Bother, Urinary Function and Urinary Bother, and Bowel Function and Bowel Bother. This is to measure not just the impact on function but also the quality of life impact. The UCLA PCI domain is scored on a scale of 0-100 points with higher values representing better outcomes.
Time Frame	Baseline through 5 years

Outcome Measure Data

Analysis Population Description

Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional.

Arm/Group Title	UCLA-PCI Sexual Function	UCLA-PCI Urinary Function	UCLA-PCI Bowel Function	UCLA-PCI Sexual Bother	UCLA-PCI Urinary Bother	UCLA-PCI Bowel Bother
Arm/Group Description	Sexual function measure	Urinary function measure	Bowel function measure	Sexual bother measure	Urinary bother measure	Bowel bother measure
Measure Participants	833	814	804	820	812	802
Baseline	21.5 (16.9)	79.9 (24.3)	85.0 (15.5)	10.8 (22.8)	76.7 (31.6)	85.5 (24.1)
1 year	70.9 (20.9)	82.6 (20.9)	88.4 (14.3)	77.3 (32.7)	81.1 (26.6)	87.3 (22.3)
2 year	70.0 (21.6)	83.4 (20.8)	87.8 (15.9)	77.9 (33.2)	80.5 (27.3)	86.5 (23.5)
3 year	71.7 (20.8)	83.8 (21.2)	87.5 (17.1)	78.8 (32.2)	79.0 (28.3)	86.8 (23.7)
4 year	70.3 (22.2)	86.0 (19.6)	87.8 (17.3)	80.7 (31.9)	79.9 (27.3)	86.6 (24.3)
5 year	71.2 (21.3)	85.9 (21.5)	86.7 (19.3)	83.1 (29.4)	80.5 (28.3)	84.8 (26.0)

Adverse Events

Time Frame	Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up.
Adverse Event Reporting Description	All device and/or procedure related events were collected for this study.
Arm/Group Title	AMS Penile Prosthesis Receipients
Arm/Group Description	Men for whom an AMS penile prosthesis is recommended AMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.
All Cause Mortality
	AMS Penile Prosthesis Receipients
	Affected / at Risk (%)	# Events
Total	44/1380 (3.2%)
Serious Adverse Events
	AMS Penile Prosthesis Receipients
	Affected / at Risk (%)	# Events
Total	36/1380 (2.6%)
Cardiac disorders
Other - Substernal Chest Pain	1/1380 (0.1%)	1
General disorders
Pain/Discomfort - Penile	1/1380 (0.1%)	1
Pain/Discomfort	1/1380 (0.1%)	1
Infections and infestations
Device Infection	11/1380 (0.8%)	13
Abscess	2/1380 (0.1%)	2
Cellulitis	1/1380 (0.1%)	1
Injury, poisoning and procedural complications
Erosion	6/1380 (0.4%)	6
Reservoir Herniation	3/1380 (0.2%)	3
Hematoma	2/1380 (0.1%)	2
Pain/Discomfort	1/1380 (0.1%)	1
Cylinder Crossover	1/1380 (0.1%)	1
Extrusion	1/1380 (0.1%)	1
Perforation - Other	1/1380 (0.1%)	1
Proximal Corporal Perforation	1/1380 (0.1%)	1
Product Issues
Device Cylinder Aneruysm/Bulge	1/1380 (0.1%)	1
Urethral Obstruction	1/1380 (0.1%)	1
Renal and urinary disorders
Urinary Retention	2/1380 (0.1%)	2
Reproductive system and breast disorders
Peyronie's Disease	1/1380 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Other - Decreased Oxygen Saturation	1/1380 (0.1%)	1
Skin and subcutaneous tissue disorders
Edema - Scrotal	1/1380 (0.1%)	1
Would Dehiscence	1/1380 (0.1%)	1
Vascular disorders
Cardiac Event - Non-specific	1/1380 (0.1%)	1
Pulmonary Embolus	1/1380 (0.1%)	1
Other (Not Including Serious) Adverse Events
	AMS Penile Prosthesis Receipients
	Affected / at Risk (%)	# Events
Total	72/1380 (5.2%)
General disorders
Pain/Discomfort	2/1380 (0.1%)	2
Migration (pump)	1/1380 (0.1%)	1
Pain/Discomfort - Groin	1/1380 (0.1%)	1
Pain/Discomfort - Other	1/1380 (0.1%)	1
Pain/Discomfort - Penile	1/1380 (0.1%)	1
Pain/Discomfort With Erections	1/1380 (0.1%)	1
Patient Dissatisfaction	1/1380 (0.1%)	1
Pain/Discomfort - Testicular	1/1380 (0.1%)	1
Other - Pinching sensation around the resevoirs	1/1380 (0.1%)	1
Immune system disorders
Allergic reaction/Hypersensitivity Reaction	1/1380 (0.1%)	1
Infections and infestations
Device Infection	5/1380 (0.4%)	5
Superficial Wound Infection	4/1380 (0.3%)	4
Cellulitis	1/1380 (0.1%)	1
Urinary Tract Infection - UTI	1/1380 (0.1%)	1
Other - Incisional drainage	1/1380 (0.1%)	1
Injury, poisoning and procedural complications
Hematoma	1/1380 (0.1%)	1
Urinary Retention	3/1380 (0.2%)	3
Erosion	5/1380 (0.4%)	5
Reservoir Herniation	4/1380 (0.3%)	4
Urethral Trauma	3/1380 (0.2%)	3
Extrusion	2/1380 (0.1%)	2
Device Placement Failure	1/1380 (0.1%)	1
Fibrous Capsule Formation	1/1380 (0.1%)	1
Perforation - Other	1/1380 (0.1%)	1
Proximal Corporal Perforation	1/1380 (0.1%)	1
Migration (Pump)	1/1380 (0.1%)	1
Hematoma	2/1380 (0.1%)	2
Other - Left distal tip migration with pain at tip of penis with intercourse	1/1380 (0.1%)	1
Other - Change in curvature of penis (increase in curvature)	1/1380 (0.1%)	1
Other - Proximal cross over during IPP surgery	1/1380 (0.1%)	1
Other - Proximal crossover	1/1380 (0.1%)	1
Investigations
Fever	1/1380 (0.1%)	1
Musculoskeletal and connective tissue disorders
Inguinal Hernia Formation	1/1380 (0.1%)	1
Pain/Discomfort	1/1380 (0.1%)	1
Product Issues
Device Cylinder Aneurysm/Bulge	3/1380 (0.2%)	3
Malposition	2/1380 (0.1%)	2
Auto Inflation	1/1380 (0.1%)	1
Fibrosis	1/1380 (0.1%)	1
Incorrect Size - Cylinders too Large	1/1380 (0.1%)	1
Pain/Discomfort	1/1380 (0.1%)	1
Migration (Pump)	1/1380 (0.1%)	1
Pain/Discomfort - Testicular	2/1380 (0.1%)	2
Other - Buckling of left cylinder led to left downward curvature	1/1380 (0.1%)	1
Other - Right cylinder protruding	1/1380 (0.1%)	1
Other - Bilateral corporal aneurysm	1/1380 (0.1%)	1
Renal and urinary disorders
Bladder Neck Obstruction	1/1380 (0.1%)	1
Hematuria	1/1380 (0.1%)	1
Urinary Retention	3/1380 (0.2%)	3
Reproductive system and breast disorders
Priapism	1/1380 (0.1%)	2
Hematospermia	1/1380 (0.1%)	1
Peyronie's Disease	1/1380 (0.1%)	1
Other - Painful mass in right hemiscrotum	1/1380 (0.1%)	1
Skin and subcutaneous tissue disorders
Adhesion of the Pump/Scrotum	1/1380 (0.1%)	1
Edema - Penile	1/1380 (0.1%)	1
Wound Dehiscence	1/1380 (0.1%)	1
Pain/Discomfort - Groin	1/1380 (0.1%)	1
Other - Slight separation of penoscrotal wound	1/1380 (0.1%)	1
Vascular disorders
Increased Blood Loss	1/1380 (0.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.